Health product recall

Mio Care Pro, Mio Care Beauty, Mio Vein, Mio Peristim, Smart TENS, Mio Care Fitness, Mio Sonic, Orthomag, and Mag 2000 Plus (2018-10-18)

Starting date:
October 18, 2018
Posting date:
November 30, 2018
Type of communication:
Medical Device Recall
Subcategory:
Medical Device, Biologic/vaccine
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-68490

Affected products

A. Mio Care Pro

B. Mio Care Beauty

C. Mio Vein

D. Mio Peristim

E. Smart TENS

F. Mio Care Fitness

G. Mio Sonic

H. Orthomag

I. Mag 2000 Plus

Reason

Unlicensed medical devices

Affected products

A. Mio Care Pro

Lot or serial number

1406000914

Model or catalog number

MIO-CARE PRO

Companies
Manufacturer

I.A.C.E.R. S.r.l.

Via Sandro Pertini, 24/A

Martellago, Venice

30030

ITALY


B. Mio Care Beauty

Lot or serial number

1308000675

Model or catalog number

MIO-CARE BEAUTY

Companies
Manufacturer

I.A.C.E.R. S.r.l.

Via Sandro Pertini, 24/A

Martellago, Venice

30030

ITALY


C. Mio Vein

Lot or serial number

1208001010

Model or catalog number

MIO-VEIN

Companies
Manufacturer

I.A.C.E.R. S.r.l.

Via Sandro Pertini, 24/A

Martellago, Venice

30030

ITALY


D. Mio Peristim

Lot or serial number

1104000157

Model or catalog number

MIOPERISTIM

Companies
Manufacturer

I.A.C.E.R. S.r.l.

Via Sandro Pertini, 24/A

Martellago, Venice

30030

ITALY


E. Smart TENS

Lot or serial number

1409000678

Model or catalog number

SMART TENS

Companies
Manufacturer

I.A.C.E.R. S.r.l.

Via Sandro Pertini, 24/A

Martellago, Venice

30030

ITALY


F. Mio Care Fitness

Lot or serial number

1411000652

Model or catalog number

MIO-CARE FITNESS

Companies
Manufacturer

I.A.C.E.R. S.r.l.

Via Sandro Pertini, 24/A

Martellago, Venice

30030

ITALY


G. Mio Sonic

Lot or serial number

15010274

Model or catalog number

MIO-SONIC

Companies
Manufacturer

I.A.C.E.R. S.r.l.

Via Sandro Pertini, 24/A

Martellago, Venice

30030

ITALY


H. Orthomag

Lot or serial number

1601000170

1601000172

Model or catalog number

ORTHOMAG

Companies
Manufacturer

I.A.C.E.R. S.r.l.

Via Sandro Pertini, 24/A

Martellago, Venice

30030

ITALY


I. Mag 2000 Plus

Lot or serial number

1509000739

1509000740

Model or catalog number

MAG 2000 PLUS

Companies
Manufacturer

I.A.C.E.R. S.r.l.

Via Sandro Pertini, 24/A

Martellago, Venice

30030

ITALY